MARLBOROUGH, Mass.--(EON: Enhanced Online News)--Sunovion
Pharmaceuticals Inc. (Sunovion) will present data on multiple
products from its broad chronic obstructive pulmonary disease (COPD)
portfolio, including data from Phase 3 efficacy and safety studies of
SUN-101/eFlow® in patients with moderate-to-very-severe COPD,
at the American Thoracic Society 2017 International Conference (ATS
2017) to be held May 19-24, 2017, in Washington, D.C.

“These presentations demonstrate our commitment to improving the lives
of patients with COPD by better understanding the treatment landscape
and advancing innovative treatment options, including nebulized and
handheld products, for patients at various stages of the disease”

The seven poster presentations from SUN-101/eFlow® clinical
studies include data that demonstrate the safety and efficacy of
SUN-101/eFlow®, a long-acting muscarinic antagonist (LAMA)
bronchodilator delivered via the proprietary, investigational eFlow®
closed system nebulizer, developed by PARI Pharma GmbH, as well as data
from a patient survey showing patient satisfaction with the eFlow®
device. Sunovion will also present data from two health economics and
outcomes research (HEOR) studies investigating the factors that
influence the use of nebulized long-acting beta agonists (LABAs) in COPD
treatment and the effect of long-acting versus short-acting
bronchodilators on COPD-related re-hospitalizations.

“These presentations demonstrate our commitment to improving the lives
of patients with COPD by better understanding the treatment landscape
and advancing innovative treatment options, including nebulized and
handheld products, for patients at various stages of the disease,” said
Thomas H. Goodin, Ph.D., Senior Director, Clinical Development at
Sunovion. “We look forward to presenting data from our portfolio of COPD
products that highlight our mission to address unmet needs for people
living with COPD.”

In October last year, Sunovion announced
that the U.S. Food and Drug Administration (FDA) accepted its New Drug
Application (NDA) for SUN-101/eFlow® as a long-term,
maintenance treatment of airflow obstruction in patients with
moderate-to-very-severe COPD. If approved, this will be the first
nebulized LAMA approved for the treatment of COPD in the U.S.

Sunovion received U.S. commercial rights for UTIBRON NEOHALER, along
with Seebri™ Neohaler® (glycopyrrolate) inhalation
powder and Arcapta® Neohaler® (indacaterol)inhalation
powder, in December 2016. Sunovion announced
on April 3, 2017 that UTIBRON NEOHALER is now available at
pharmacies in the U.S. The Company expects to launch SEEBRI NEOHALER,
which was approved by the FDA in 2015, and begin promotion of ARCAPTA
NEOHALER, which was launched in the U.S. in 2012, in the U.S. during
fiscal year 2017 (April 2017-March 2018).

About SUN-101/eFlow®

SUN-101 (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA)
bronchodilator delivered via the proprietary investigational eFlow®
closed system nebulizer. SUN-101/eFlow® is currently in
development as a nebulized treatment for patients with
moderate-to-very-severe chronic obstructive pulmonary disease (COPD).
The investigational combined product, consisting of SUN-101 and the eFlow®
closed system nebulizer, which has been optimized for SUN-101 delivery,
has not been approved by the U.S. Food and Drug Administration (FDA) for
the treatment of COPD.

About Long Acting Muscarinic Antagonists (LAMAs)

A long-acting muscarinic antagonist (LAMA) is a type of long-acting
bronchodilator, along with long-acting beta agonists (LABAs). According
to the GOLD report, these are currently the first-line standard of care
maintenance therapy for symptomatic patients with COPD and help the
muscles around the airways in lungs stay relaxed to prevent symptoms
such as wheezing, coughing, chest tightness, and shortness of breath.1
LAMAs and LABAs are widely used and important therapeutic approaches for
people with COPD.

About the Phase 3 GOLDEN Clinical Trials

GOLDEN-3 and GOLDEN-4 were pivotal Phase 3, 12-week, randomized,
double-blind, placebo-controlled, parallel-group, multicenter, efficacy
and safety trials comparing SUN-101/eFlow® with placebo in
adults with moderate-to-very severe COPD. The GOLDEN-3 trial enrolled
653 people who were at least 40 years old at 45 sites in the United
States. The GOLDEN-4 trial enrolled 641 people who were at least 40
years old at 49 sites in the United States. SUN-101/eFlow® 25
mcg, SUN-101/eFlow® 50 mcg or placebo was administered twice
daily in these studies. The primary endpoint was the change from
baseline in trough FEV1 at Week 12. Secondary endpoints
included standardized change from baseline at Week 12 in FEV1
area under the curve (AUC), change from baseline in trough forced vital
capacity (FVC) at Week 12, change from baseline in health status
measured by St. George’s Respiratory Questionnaire and change in rescue
medication use. Safety was assessed by the number of treatment-emergent
adverse events (TEAE), serious adverse events (SAE) or major adverse
cardiac events (MACE) and the number and percentage of study
participants who discontinued the study due to TEAE. Both GOLDEN-3 and
GOLDEN-4 studies included not only patients who were taking effective
background long-acting bronchodilator therapy but also patients with
very severe disease and co-existing significant cardiovascular illness.
Approximately 10 percent of the population were elderly (>75 years), 65
percent were classified as being high-risk cardiovascular patients and
more than 30 percent were taking long-acting bronchodilator therapy
[NCT02347761 and NCT02347774].

GOLDEN-5 was a Phase 3, 48-week, randomized, open-label,
active-controlled, parallel-group, multicenter safety trial designed to
evaluate the long-term safety and tolerability of SUN-101/eFlow®
in adults with moderate-to-very severe COPD. The study enrolled 1,087
patients at 111 investigational sites in the United States and Europe.
The study evaluated 50 mcg of SUN-101/eFlow® delivered
twice-daily and active comparator 18 mcg of Spiriva®
(tiotropium bromide) delivered once-daily by the HandiHaler®
device. The primary safety endpoints were: the number and percentage of
study participants with treatment-emergent adverse events (TEAE), the
number and percentage of study participants with treatment-emergent
serious adverse events (SAE) and the number and percentage of study
participants who discontinued the study due to TEAEs. The secondary
endpoints were the number and percentage of subjects with MACE and the
mean change from baseline over 48 weeks in trough FEV1 for all subjects
and. The study included not only patients who were taking effective
background long acting bronchodilator therapy but also patients with
very severe disease and co-existing significant cardiovascular illness.
Approximately 10 percent of the population were elderly (>75 years), 65
percent were classified as being high-risk cardiovascular patients and
more than 40 percent were taking long-acting bronchodilator therapy
[NCT02276222].

About Utibron™ Neohaler® (indacaterol/glycopyrrolate)
Inhalation PowderUTIBRON NEOHALER (indacaterol/glycopyrrolate)
inhalation powder is a twice-daily combination long-acting beta agonist
and long-acting muscarinic antagonist (LABA/LAMA) approved in the U.S.
for the long-term maintenance treatment of airflow obstruction in people
with COPD, including chronic bronchitis and/or emphysema. Phase 3
clinical trials demonstrated that UTIBRON NEOHALER has the additive
benefits of the LABA indacaterol and the LAMA glycopyrrolate compared to
each component alone. UTIBRON NEOHALER also improved overall quality of
life as measured by the St. George’s Respiratory Questionnaire (SGRQ)
total score, reduced COPD rescue medication use and improved
breathlessness as measured by the Transitional Dyspnea Index (TDI) total
score in patients as compared to placebo.

INDICATIONUTIBRON™ NEOHALER® (indacaterol and
glycopyrrolate) is a combination of a long-acting beta2-agonist,
or LABA, medicine (indacaterol) and an anticholinergic medicine
(glycopyrrolate). UTIBRON NEOHALER is used long term, twice each day
(morning and evening), to treat the symptoms of chronic obstructive
pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

IMPORTANT SAFETY INFORMATION

UTIBRON NEOHALERhas been approved for COPD only and is NOT
indicated for the treatment of asthma. People with asthma who take
long-acting beta2-adrenergic agonist (LABA)
medicines, such as indacaterol (one of the medicines in UTIBRON
NEOHALER), have an increased risk of death from asthma problems. It is
not known if LABA medicines, such as indacaterol, increase the risk of
death in people with COPD.

UTIBRON NEOHALER does not relieve sudden symptoms of COPD and should not
be used more than twice daily. Always have a short-acting beta2-agonist
with you to treat sudden symptoms.

Use UTIBRON NEOHALER exactly as your health care provider tells you to
use it. Do not use UTIBRON NEOHALER more often than it is prescribed for
you.

Get emergency medical care if your breathing problems worsen quickly,
you need to use your rescue medication more often than usual, or your
rescue medication does not work as well to relieve your symptoms.

Do not use UTIBRON NEOHALER if you are allergic to indacaterol,
glycopyrrolate, or any of the ingredients in UTIBRON NEOHALER. Ask your
health care provider if you are not sure.

Tell your health care provider about all of your health conditions,
including if you:

have heart problems

have high blood pressure

have seizures

have thyroid problems

have diabetes

have liver problems

have kidney problems

have eye problems such as glaucoma

have prostate or bladder problems, or problems passing urine

have any other medical conditions

are pregnant or plan to become pregnant

are breastfeeding or plan to breastfeed

are allergic to UTIBRON NEOHALER or any of its ingredients, any other
medicines, or food products. UTIBRON NEOHALER contains lactose (milk
sugar) and a small amount of milk proteins. It is possible that
allergic reactions may happen in people who have a severe milk protein
allergy

Tell your health care provider about all the medicines you take,
including prescription medicines, over-the-counter medicines, vitamins,
and herbal supplements. UTIBRON NEOHALER and certain other medicines may
interact with each other. This may cause serious side effects.

sudden shortness of breath (that may be life-threatening) immediately
after use of UTIBRON NEOHALER

increased blood pressure

fast or irregular heartbeat (palpitations)

chest pain

serious allergic reactions, including rash; hives; swelling of the
tongue, lips, and face; and difficulties breathing or swallowing. Call
your health care provider or get emergency medical care if you get any
symptoms of a serious allergic reaction

new or worsened eye problems, including acute narrow-angle glaucoma
(symptoms may include eye pain or discomfort, blurred vision, red
eyes, nausea or vomiting, seeing halos or bright colors around lights)

new or worsened urinary retention (symptoms may include difficulty
urinating, urinating frequently, painful urination, urination in a
weak stream or drips)

changes in laboratory blood levels, including high levels of blood
sugar (hyperglycemia) and low levels of potassium (hypokalemia), which
may cause symptoms of muscle spasm, muscle weakness, or abnormal heart
rhythm

Common side effects of UTIBRON NEOHALER include sore throat and runny
nose, high blood pressure, and back pain.

These are not all of the possible side effects with UTIBRON NEOHALER.
Tell your health care provider about any side effect that bothers you or
that does not go away.

Do not swallow UTIBRON capsules. UTIBRON capsules are for inhalation
only with the NEOHALER device. Never place a capsule in the mouthpiece
of the NEOHALER device.

You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.

About NEOHALER® InhalerThe
NEOHALER inhaler is a handheld device designed to deliver UTIBRON,
SEEBRI and ARCAPTA. The NEOHALER inhaler offers several feedback
mechanisms that allow patients to see whether or not the capsules are
empty, while giving them the flexibility to inhale any remaining dose
not fully administered. The ability to provide dosing feedback is an
important feature for patients and physicians. The NEOHALER inhaler is
also small enough to carry easily in a pocket, bag or purse.

About COPDChronic obstructive pulmonary disease (COPD) is a
common, preventable and treatable disease that is characterized by
persistent respiratory symptoms and airflow limitation that is due to
airway and/or lung abnormalities usually caused by significant exposure
to toxic particles or gases. The main risk factor for COPD is tobacco
smoking, but other environmental exposures may contribute.1 Approximately
15.7 million adults in the U.S. report that they have been diagnosed
with COPD.2 It is estimated that several million more adults
have undiagnosed COPD.3 COPD is responsible for over 120,000
deaths per year, making it the third leading cause of death in the U.S.3 COPD
develops slowly and the symptoms often worsen over time, potentially
limiting the ability to perform routine activities.2 Symptoms
of COPD include coughing, wheezing, shortness of breath, excess
production of mucus in the lungs, the inability to breathe deeply and
the feeling of being unable to breathe.4 The symptoms of COPD
can be most severe during the night and early morning.5 Morning
symptoms can be associated with limitation of activities during the day,
impaired health status and increased risk of exacerbation.6
Night-time symptoms disturb sleep, reduce sleep quality and, in the long
term, may be associated with development or worsening of cardiovascular
diseases, cognition, depression and increased mortality.7

Expanding Sunovion’s Heritage in COPDSunovion is committed
to expanding its heritage of advancing new treatments for serious
respiratory medical conditions, including the 15.7 million people in the
U.S. who are living with chronic obstructive pulmonary disease (COPD).2
The company offers the broadest COPD portfolio in the U.S., providing
treatment options for people at various stages of COPD, as well as the
flexibility for health care providers and patients to choose handheld or
nebulized products based on individual treatment needs. Sunovion goes
beyond treatment offerings to support awareness and understanding with
the entire COPD community – health care providers, patients and
caregivers – and to advancing disease state education through its
partnerships with various organizations.

About Sunovion Pharmaceuticals Inc. (Sunovion)Sunovion is a
global biopharmaceutical company focused on the innovative application
of science and medicine to help people with serious medical conditions.
Sunovion’s vision is to lead the way to a healthier world. The company’s
spirit of innovation is driven by the conviction that scientific
excellence paired with meaningful advocacy and relevant education can
improve lives. With patients at the center of everything it does,
Sunovion has charted new paths to life-transforming treatments that
reflect ongoing investments in research and development and an
unwavering commitment to support people with psychiatric, neurological
and respiratory conditions. Sunovion’s track record of discovery,
development and commercialization of important therapies has included
Utibron™ Neohaler® (indacaterol/glycopyrrolate) inhalation
powder, Brovana® (arformoterol tartrate) inhalation solution,
Latuda® (lurasidone HCI) and Aptiom®
(eslicarbazepine acetate).

Headquartered in Marlborough, Mass., Sunovion is an indirect,
wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion
Pharmaceuticals Europe Ltd., based in London, England, Sunovion
Pharmaceuticals Canada Inc., based in Mississauga, Ontario, and Sunovion
CNS Development Canada ULC, based in Toronto, Ontario, are wholly-owned
direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional
information can be found on the company’s web sites: www.sunovion.com,
www.sunovion.eu
and www.sunovion.ca.
Connect with Sunovion on Twitter,
LinkedIn,
Facebook
and YouTube.

About Sumitomo Dainippon Pharma Co., Ltd.Sumitomo Dainippon
Pharma is among the top-ten listed pharmaceutical companies in Japan
operating globally in major pharmaceutical markets, including Japan, the
United States, China and the European Union. Sumitomo Dainippon Pharma
aims to create innovative pharmaceutical products in the Psychiatry &
Neurology area and the Oncology area, which have been designated as the
focus therapeutic areas. Sumitomo Dainippon Pharma is based on the
merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo
Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has about
6,500 employees worldwide. Additional information about Sumitomo
Dainippon Pharma is available through its corporate website at www.ds-pharma.com.

LATUDA and SUNOVION are registered trademarks of Sumitomo Dainippon
Pharma Co., Ltd.BROVANA is a registered trademark of Sunovion
Pharmaceuticals Inc.APTIOM is used under license from Bial.ARCAPTA
and NEOHALER are registered trademarks of Novartis AG, used under
license. SEEBRI and UTIBRON are trademarks of Novartis AG, used under
license.eFlow® is a registered trademark of PARI Pharma GmbH.Spiriva®
and HandiHaler® are registered trademarks of Boehringer Ingelheim Pharma
GMBH & Co KG.

Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon
Pharma Co., Ltd.

MARLBOROUGH, Mass.--(EON: Enhanced Online News)--Sunovion will present 10 research posters on Latuda® (lurasidone HCI) and five posters on the investigational agent dasotraline at the Psych Congress. more »